Zwick USA to demonstrate capabilities for functional and safety testing of products at CPhl
Kennesaw, GA – Zwick USA will demonstrate powerful capabilities for functional and safety testing of combination products such as prefilled syringes, insulin pens or autoinjectors at the upcoming CPHI North America Exhibition to be held in Philadelphia at the Philadelphia Convention Center May 16-18.
Subject matter experts from Zwick USA will be at booth #3233 to address customer application questions and to provide detailed product demonstrations. With market demand for testing of parenteral drug delivery devices on the rise, we will demonstrate our compact, innovative zwickiLine testing machine equipped with a torsion drive to support various critical functional tests such as the pull-out force and torque for Luer Lock conical fittings in accordance with ISO 594-1or the dosing accuracy of insulin pens to ISO 11608-1.
Visitors to Zwick USA’s booth will also have the opportunity to experience our state-of-the-art testXpert III testing software and the support it lends customers for maintaining compliance with FDA 21 CFR Part 11. Our zwickiLine testing systems work in concert with innovative features in our testXpert III software to deliver the highest levels of measurement accuracy, to ease the process of test setup, and to conserve time in the test lab.
“Both vertically integrated manufacturers and contract manufacturing organizations involved in the design, development and production of prefilled syringes, insulin pens and autoinjectors require a turnkey solution that can accommodate the entire range of tests for quality assurance and safety. Our zwickiLine solution is an optimal platform for functional testing and for testing in accordance with international standards,” said Lorraine McLean, Medical Industry Manager for Zwick USA.
The zwickiLine testing system is available with a wide range of load cells, delivering accurate measurements in the range of tens of Newtons. An optional torsion drive supports torsion testing in combination with tensile or compression. A wide range of grips and fixtures combine with test rigs that enable customers to evaluate device performance in various areas.
“We are pleased to demonstrate the versatility and flexibility of our systems at CPHI North America 2017,” said McLean. “In addition to a large range of specialized fixtures developed expressly for pharmaceutical applications, we offer an expanded traceability option in our testXpert III testing software to support regulatory compliance. With industry regulation growing ever more stringent, we are responding to customer needs in areas such as electronic recordkeeping.”
FDA 21 CFR Part 11 requires medical device manufacturers, pharmaceutical companies, biotech companies and other FDA-regulated entities to implement controls, including audits, system validations, audit trails, electronic signatures, and documentation for software and systems involved in processing electronic data that are required to be maintained by the FDA predicate rules or used to demonstrate compliance to a predicate rule.
Zwick USA offers solutions that are in accordance with FDA 21 CFR Part 11 during the design and test of medical and drug delivery devices with its testXpert III measurement and control software. The option for expanded traceability offers all tools required to fulfill the requirements set forth by the FDA in 21 CFR Part 11.
Further information on Zwick testing solutions for applications in the pharmaceutical industry may be found here: http://www.zwickusa.com/en/applications/medical-industry/therapy-systems.html
About Zwick USA
Zwick USA engages, services and supports the North American material and component testing marketplace. Capitalizing on Zwick/Roell AG’s 150-year legacy of quality and reliability, Zwick USA has provided cutting edge solutions to customers in North America for more than 20 years. Zwick USA continues its emphasis on excellence, pairing the latest developments in test technologies with industry-leading software to address increasingly demanding applications. Further information about Zwick USA is available at www.zwickusa.com